Unique ID issued by UMIN | UMIN000007982 |
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Receipt number | R000009397 |
Scientific Title | A verification study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects. |
Date of disclosure of the study information | 2012/05/25 |
Last modified on | 2016/04/09 12:04:08 |
A verification study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
Drug interaction study between Midazolam and Anchu-san.
A verification study to investigate the drug interaction via CYP3A between oral Midazolam administration and miltiple Anchusan dose in Janaese male subjects.
Drug interaction study between Midazolam and Anchu-san.
Japan |
Japanese healthy male
Adult |
Others
NO
The pilot study that previously conducted (UMIN ID:000006655) suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam dose. Therefore the verification study will be conducted with increased number of study subjects. This is a verification study to investigate the effects of the 6 days Anchu-san multiple dose (7.5/day) on the pharmacokinetics of oral administration of midazolam (7.5mg) in Japanese healthy male subjects.
The pharmacodynamic interaction between midazolam and Anchu-san will also be investigated.
PK,PD
Confirmatory
Explanatory
Not applicable
The pharmacokinetic parameters of midazolam in serum (AUC 0-10, Cmax, t1/2, tmax).
The sedative action after midazolam oral administration: VAS
Safety assessment (pulse oximeter, vital measurement, adverse event)
Interventional
Cross-over
Non-randomized
Open -no one is blinded
No treatment
2
Prevention
Medicine |
Midazolam single oral administration
Midazolam single oral administration after 6 days Anchu-san (7.5g/day) dose
20 | years-old | <= |
45 | years-old | > |
Male
1) Age: 20 - 45 years old at the time of informed consent
2)Sex: male
3) Subjects are competent to consent, keep the rules of the study and are able to report self condition.
4) Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study.
1) Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug abuse, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood etc) and who is taking any drugs (including health supplements).
2) Any history for drug allergy
3) Subjects who are taking in too much alcohol (those who cannot maintain the abstains from alcohol during study period)
4) Subjects within three months after the participation to other clinical trials
5) Subjects who are inadequate for enrollment judged by the investigator.
6
1st name | |
Middle name | |
Last name | Naoki Uchida MD, PhD |
Showa University School of Medicine
Department of Clinical Pharmacology
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
03-3784-8128
nuchida@med.showa-u.ac.jp
1st name | |
Middle name | |
Last name | Hirokazu Toshima MD |
Showa University School of Medicine
Department of Clinical Pharmacology
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
03-3784-8128
showa_northern@yahoo.co.jp
Showa University School of Medicine Department of Clinical Pharmacology
None
Self funding
NO
昭和大学臨床薬理研究センター(東京都)
Showa University Clinical Trial Center for Clinical Pharmacology (Tokyo)
2012 | Year | 05 | Month | 25 | Day |
Published
This study was performed in 7 subjects. No adverse event was observed during the study in all subjects.
Mean value of PK parameter of plasma Midazolam are as follows;
Pre-dose of Anchu-san
Cmax:64.99+/-18.61ng/mL, AUC:192.59+/-78.13ng*hr/mL
After 7 days Anchu-san dose
Cmax:88.66+/-16.37ng/mL, AUC:249.06+/-72.84ng*hr/mL
No difference was observed in VAS scale between pre- and post- Anchu-san dose.
It was suggested that 7 days oral Anchu-san administration would affect on PK of oral Midazolam dose.
J. Showa Med Assoc.(in print)
Completed
2012 | Year | 05 | Month | 25 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 11 | Month | 01 | Day |
2012 | Year | 11 | Month | 01 | Day |
2012 | Year | 11 | Month | 01 | Day |
2012 | Year | 05 | Month | 18 | Day |
2016 | Year | 04 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009397
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